Immunogenicity of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in subpopulations of healthy adults 18–70 years of age

Janssen, Julia M.; Jackson, Simon A.; Heyward, William L.; Janssen, Robert S.

doi:10.1016/j.vaccine.2015.05.070

Cited by 44 publications

(24 citation statements)

References 17 publications

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“…20 After that, a large number of studies showed that antibody responses to hepatitis B vaccine were significantly reduced in obese individuals compared with those non-obese people. [21][22][23][24] Moreover, the study conducted by Dinelli et al reported that the obese women who did not response to 6 doses of recombinant hepatitis B vaccine, was seroconverted after weight reduction. 25 To further understand the impaired responses of HBV vaccination, we recently performed a meta-analysis to characterize the relationship between obesity and immune response to hepatitis B vaccine.…”

Section: Discussionmentioning

confidence: 99%

Influences of obesity on the immunogenicity of Hepatitis B vaccine

Liu¹,

Guo

Dong

2017

Human Vaccines & Immunotherapeutics

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Objective: Hepatitis B vaccine is regarded as the most effective method for the prevention of hepatitis B virus (HBV) infection. However, several factors such as age, body mass index and immunocompetent state have been reported to be associated with reduced immunization responses. The present commentary was aimed to discuss the influences of obesity on the immunogenicity of hepatitis B vaccines. Data sources: Available peer-reviewed literatures, practice guidelines, and statistics published on hepatitis B vaccine in obesity between 1973 and 2015. Conclusions: Obesity was significantly associated with non-response to hepatitis B vaccine immunization. The risk of nonresponsiveness of hepatitis B vaccine among obese people increased with BMI. Moreover, the obesity might lead to an increased risk of HBV vaccine-escape mutations. The mechanism responsible for decreased immunization responses in obesity included leptininduced systemic and B cell intrinsic inflammation, impaired T cell responses and lymphocyte division and proliferation. Therefore, more studies should be performed to analyze the influences of obesity on the immunogenicity of hepatitis B vaccines to improve the immunoprotecive effect of hepatitis B vaccines in future.

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Section: Discussionmentioning

confidence: 99%

Influences of obesity on the immunogenicity of Hepatitis B vaccine

Liu¹,

Guo

Dong

2017

Human Vaccines & Immunotherapeutics

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“…Specific groups of patients respond poorly or not at all to conventional HBV vaccines. Because of the poor immunogenicity of HBsAg, new methods are needed to improve the ability of the HBV vaccine to trigger protective immunity [2, 3]. Third-generation HBV vaccines that combine small S antigen with PreS1 and PreS2 antigens have been shown to induce a stronger immune response in non- and low responders than current HBV vaccines [4].…”

Section: Introductionmentioning

confidence: 99%

A Pre-Clinical Safety Evaluation of SBP (HBsAg-Binding Protein) Adjuvant for Hepatitis B Vaccine

Wang

Liu

et al. 2017

PLoS ONE

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Although adjuvants are a common component of many vaccines, there are few adjuvants licensed for use in humans due to concerns about their toxic effects. There is a need to develop new and safe adjuvants, because some existing vaccines have low immunogenicity among certain patient groups. In this study, SBP, a hepatitis B surface antigen binding protein that was discovered through screening a human liver cDNA expression library, was introduced into hepatitis B vaccine. A good laboratory practice, non-clinical safety evaluation was performed to identify the side effects of both SBP and SBP-adjuvanted hepatitis B vaccine. The results indicate that SBP could enhance the HBsAg-specific immune response, thus increasing the protection provided by the hepatitis B vaccine. The safety data obtained here warrant further investigation of SBP as a vaccine adjuvant.

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“…After reviewing full text, 13 publication were excluded, among which nine articles did not contain an adequate methodology description in randomisation and blind methods, one article was without HBsAg-Eng as a control group [15], one article had an obscure vaccination schedule and difficulty in extracting relevant data [16], and two articles had data that could not be obtained from figures or tables [17,18]. For using raw data from same the RCTs, two articles were excluded [19,20]. Eventually, four RCTs were included in our meta-analysis [21][22][23][24].…”

Section: Study Screeningmentioning

confidence: 99%

Comparative analysis of the safety and efficacy of HBsAg-1018 versus HBsAg-Eng: a meta-analysis

Zhang¹,

Guo²,

Duan³

2019

cejoi

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Introduction: In addition to alum adjuvant, a wide diversity of adjuvants have been developed to enhance immune response of hepatitis B virus (HBV) vaccine in varying subjects, either in healthy vaccinators or subjects with hypo-immunity. In this context, a novel HBV vaccine HBsAg-1018, formulated with a toll-like receptor 9 agonist, was developed, and is currently in the phase of clinical trials. So, the first meta-analysis was performed to examine the safety and immune response of HBsAg-1018 among varying subjects. Material and methods: On the basis of inclusion criterion, eligible studies that reported safety and immunogenicity induced by HBsAg-1018 vaccination in randomised, controlled trials (RCTs) were involved from three databases: PubMed, EMBASE, and the Cochrane Library, and further confirmed by two reviewers. Meta-analysis was conducted using RevMan 5.3. The pooled relative risk (RR) for safety and immunogenicity was calculated using random-effects or fixed-effects models according to the heterogeneity of included studies. The methodology quality of eligible studies was assessed using the Cochrane Handbook for Systematic Reviews of Interventions version 5.1.0. Results: In total 5073 subjects administrated with HBV vaccine from four eligible publications were included in this meta-analysis. The data related to immunogenicity and safety post vaccination were pooled for meta-analysis. For safety, the combined RRs for adverse reactions were 0.98

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Immunogenicity of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in subpopulations of healthy adults 18–70 years of age

Cited by 44 publications

References 17 publications

Influences of obesity on the immunogenicity of Hepatitis B vaccine

Influences of obesity on the immunogenicity of Hepatitis B vaccine

A Pre-Clinical Safety Evaluation of SBP (HBsAg-Binding Protein) Adjuvant for Hepatitis B Vaccine

Comparative analysis of the safety and efficacy of HBsAg-1018 versus HBsAg-Eng: a meta-analysis

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